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To determine the effect of foot reflexology in primary open angle glaucoma (POAG) patients and the effect of a shoe insert to perform continuous foot reflexology in ocular hypertensive (OHTN) patients.
This is a prospective pilot study in glaucoma patients and a prospective therapeutic trial in ocular hypertensive patients. Patients were recruited from the Temple Ophthalmology outpatient clinic. Primary open-angle glaucoma patients were recruited from those about to have SLT for additional intraocular pressure (IOP) lowering. OHTN patients were recruited from the clinic. The glaucoma patients performed a 5-minute foot massage on a foot massage board and the IOP was checked pre-massage, post-massage and 30, 60, 90 and 120 min post massage. OHTN patients underwent a one-month drop washout and then performed a 5-minute massage using a 3D-printed shoe insert with the identical pressure checks. They then were randomly assigned to wear the shoe insert or a sham insert for one day. IOP was checked before inserting the insert and at the end of the day. The number of steps was recorded each day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma Group | Experimental | Patients with glaucoma come in and get an intraocular pressure check at baseline. They get a 5 minute foot massage and then have their intraocular pressure checked every 30 minutes over 2 hour span. |
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| Ocular Hypertension Group A | Experimental | Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again. |
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| Ocular Hypertension Group B | Active Comparator | Patients with OHTN come in and get an IOP check at baseline. They get a 5 minute foot massage and then have their IOP checked every 30 minutes over 2 hour span. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received sham flat shoe insert. Patients come back in the afternoon to have their IOP checked again. 2 week washout period and then patients return. Patients come in the morning to have their IOP checked. Received raised experimental shoe insert. Patients come back in the afternoon to have their IOP checked again. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Massage | Device | Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Changes in Glaucoma Patients | Glaucoma Patients | Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours |
| Intraocular Pressure Changes in Ocular Hypertensive Patients | Ocular Hypertensive Patients | Collect pressure readings for baseline, after 5 minutes of massage, and every 30 minutes for 2 hours |
| Intraocular Pressure Changes in Ocular Hypertensive Patients | Ocular Hypertensive Patients | Baseline and after experimental foot insert intervention, over an average of 8 hours |
| Intraocular Pressure Changes in Ocular Hypertensive Patients | Ocular Hypertensive Patients | Baseline and after sham foot insert intervention, over an average of 8 hours |
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The inclusion criteria for this study in each study group are as follows.
The exclusion criteria for BOTH study groups will be:
Additional exclusion criteria for the Foot Insert ONLY will be:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital Ophthalmology Clinic | Philadelphia | Pennsylvania | 19140 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2022 | May 31, 2022 | 2 |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Experimental insert | Procedure | Raised shoe insert, insert used for massage |
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| Sham insert | Procedure | Flat shoe insert, insert used for massage |
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| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |